Drugmakers prepare to disclose doctor payments

WASHINGTON — Drug companies and medical-device makers would be forced to publicly disclose any money paid to doctors under new U.S. regulations designed to make patients aware of conflicts of interest that may affect their health.

The final rule, a provision in President Obama's health law that is more than a year overdue, is set to be released soon, said Brian Cook, a spokesman for the Centers for Medicare and Medicaid Services. Companies would have to publish payments to doctors for research and consulting services.

The rules would for the first time give patients a peek at a doctor's financial link to drugmakers, information that regulators have long been privy to yet typically kept to themselves. Expanded public disclosure may bring more scrutiny on physicians that serve on advisory panels that help the Food and Drug Administration decide whether to approve a new drug.

"The question is whether there's some residual fondness for the company because they did pay you," Sidney Wolfe, director of the health policy research group at the consumer watchdog group Public Citizen. "More disclosure is better."

For years, doctors who sat on FDA advisory panels have had to inform the agency about conflicts of interest. The agency determines when a waiver for a financial conflict may be necessary and otherwise keeps arrangements between doctors and companies secret, even from other panel members. At least 12 drugmakers, including Pfizer and Johnson & Johnson, started making those disclosures public in anticipation of the new regulations.

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The Pharmaceutical Research and Manufacturers of America, the primary lobbying group in Washington for drugmakers, said that while it supports more disclosure, the new regulations should take into account "the importance of context in the publication of physician payment information."

"Ethical interactions between biopharmaceutical companies and health-care professionals are essential to maintaining patient trust," Matthew Bennett, a spokesman for PhRMA, said in an email. The principle behind the so-called Sunshine provision "is complementary to this belief and it has great potential for helping patients understand the ways in which" such collaboration benefits their health and medical innovation, Bennett said.

The Obama administration hasn't explained why the rules are delayed, Grassley said. The Sunshine provision, which was part of the Affordable Care Act signed into law in 2010, was supposed to be issued by October 2011. The Centers for Medicare and Medicaid Services is "working to release the regulations as soon as possible," Cook said in an email.

Sen. Charles Grassley, R-Iowa, wrote the White House on Tuesday urging officials to release the regulation today or name a date it would be issued.

"Letting the sun shine in and making information public is basic to accountability," Grassley, the top Republican on the Senate Judiciary Committee, said in the letter to White House Chief of Staff Jacob Lew. "The sooner we can properly implement this law, the sooner we can establish greater accountability for patients and consumers, especially with medical research."

Congress designed the provision so data would be publicly available by the end of September 2013, Grassley said. Now that the regulation is 15 months overdue, the public may miss an entire year's worth of data collection because companies need at least a year to comply, he said.

When the FDA reviews applications for new drugs and medical devices, it relies on outside doctors, academics and researchers for insight and recommendations on the safety, effectiveness and need for the products. Watchdogs, including the Washington-based Public Citizen and Project on Government Oversight, have cited instances where doctors advising the FDA on a particular medicine had also been paid to consult for the product's maker.

The Project on Government Oversight has asked the FDA to post advisory committee members' financial disclosure forms online since 2010. The group wrote the FDA a year ago urging the agency to do so again after four advisers who backed Bayer AG's Yaz and its class of birth control pills against concern that they may have higher risk of blood clots were found to have done work for Leverkusen, Germany-based Bayer or a company that make generic versions of the pills.

During the December 2011 meeting, the FDA said there wasn't a conflict of interest. The vote in favor of the class of oral contraceptives containing the hormone drospirenone was 15-11.

The issue was brought to light again in November when Dynavax Technologies' experimental hepatitis B vaccine failed to win the backing of FDA advisers despite a positive regulatory review just days before. A search through the website of GlaxoSmithKline, which does disclose doctor payments, revealed the chairman of that advisory panel previously did work for Glaxo, which has a similar product already on the market.

The chairman, Robert Daum, a professor of pediatrics at the University of Chicago received $4,646 from Glaxo for consulting in 2009, according to the London-based company's website. Daum was the only panel member to vote against the efficacy of the vaccine. On a separate vote, the panel split 8-5 in saying Dynavax didn't have adequate safety data to support approval.

The FDA was aware of the payments and didn't consider them a financial interest that warranted a waiver or interfered with Daum's ability to sit on the panel, Rita Chappelle, an agency spokeswoman said in an e-mail.

Daum said in a telephone interview that his past relationship with Glaxo, which was for work on a different type of vaccine, didn't influence his vote.

"I don't think that kind of funding in the distant past would influence my votes," he said. "I think you have to have some faith in the integrity of the people you've asked to serve."

He wasn't sure whether the FDA should be required to disclose his relationships with drugmakers regardless.

Michael Ostrach, vice president and chief business officer for Berkley, California-based Dynavax, declined to comment on Daum.

"In areas of medicine that are popular these days, I think it's hard to find enough skilled reviewers without possible conflicts of interest and this means that a good committee may have a few such members with possible conflicts," Ned Feder, a staff scientist with the Project on Government Oversight, said.

In May, the FDA had 634 advisory committee positions and 106 were vacant, according to the latest data on the agency's website. This compares with 608 positions in May 2010 and 216 vacancies.

"The solution, I think, is not to insist on limiting committees to members without conflicts," Feder said. "Simply disclose the financial arrangements of all committee members."

Allan Coukell, director of medical programs for the Pew Health Group in Washington, agreed, saying some financial relationships between doctors and drugmakers are necessary and beneficial like payments for research.

"No drug can be developed or tested without the participation of physicians who enroll patients in clinical trials," Coukell said in a telephone interview. "That's an essential part of drug development and we need it to continue."